BILL ANALYSIS Ó AB 1069 Page 1 ASSEMBLY THIRD READING AB 1069 (Gordon) As Amended May 6, 2015 Majority vote ----------------------------------------------------------------- |Committee |Votes |Ayes |Noes | | | | | | | | | | | |----------------+------+--------------------+--------------------| |Health |17-0 |Bonta, Maienschein, | | | | |Bonilla, Burke, | | | | |Chávez, Chiu, | | | | |Gomez, Gonzalez, | | | | |Lackey, Patterson, | | | | |Ridley-Thomas, | | | | |Rodriguez, | | | | |Santiago, | | | | |Steinorth, | | | | |Thurmond, Waldron, | | | | |Wood | | | | | | | | | | | | ----------------------------------------------------------------- SUMMARY: Modifies the handling and repackaging requirements for donated pharmaceuticals at voluntary, county-operated prescription drug collection and distribution programs. AB 1069 Page 2 EXISTING LAW: 1)Establishes a voluntary, county-operated prescription drug collection and distribution program (Program) to distribute surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. 2)Establishes the California Board of Pharmacy (BOP) to regulate the practice of pharmacy and enforce the pharmacy law. Authorizes the BOP to adopt rules and regulations pertaining to establishments wherein any drug or device is compounded, prepared, furnished, or dispensed. FISCAL EFFECT: None COMMENTS: The author states that this bill is necessary to improve current and future Programs by making two necessary operational changes which will allow for the packaging of medications in advance and allow for transfers to non-adjacent counties. When the Program was initially enacted, it was one of the first in the country and had few examples to draw from. The Program has been operational for almost five years and has provided enough medications to fill over 30,000 prescriptions. According to the author, it has become evident that improvements are needed to help streamline the program's operations, encourage additional counties to participate, and help more low-income Californians get the medicine that they need to stay healthy. Background. The Program was created by SB 798 (Simitian), Chapter 444, Statutes of 2005, and SB 1329 (Simitian), Chapter 709, Statutes of 2012, which authorize counties to establish a system to facilitate the collection and distribution of surplus unused medications to medically indigent persons. To date, two counties in California (Santa Clara and San Mateo) have established a AB 1069 Page 3 Program through local ordinance, although Santa Clara is the only county currently operating a Program. Supporting Initiatives to Redistribute Unused Medicine (SIRUM), the sponsor of this bill, is a tax-exempt nonprofit organization that connects safety-net clinics with unexpired, unopened donated drugs from suppliers, pharmacies, and health facilities. SIRUM works with Santa Clara County through their Program. SIRUM has reported that over 150 participating health facilities currently donate eligible medication. An October 2013 California Healthline report stated that, to date, SIRUM had administered the redistribution of 444,380 units of medicine worth about $1.5 million wholesale. Similar Programs in Other States. According to the National Conference of State Legislatures, as of January 2015, at least 38 states and Guam have enacted laws and programs which are similar to the Program a county may establish under current California law. While many other state programs exist at the state level or as part of a statewide effort, California is unique in that a Program is established at the county level. Support. SIRUM, sponsor of this bill, states that this bill will increase access to necessary, and in many cases life-sustaining, prescription drugs to medically indigent Californians while at the same time reducing the environmental impact of pharmaceutical waste. SIRUM states that with shrinking budgets for the healthcare safety net and rising healthcare costs for all Californians, enacting this bill would allow California to maximize quality patient care by reducing the financial burden of pharmaceutical acquisitions and promote environmentally sustainable healthcare practices. The Santa Clara County Board of Supervisors states that improving this program would encourage more counties to consider implementation of a drug collection and distribution program. AB 1069 Page 4 Opposition. The BOP opposes this bill because it would create conflicts between state and federal law. Regulation of drug distribution is complex, with a myriad of state and federal laws designed to ensure the safety and efficacy of prescription drugs. BOP states that they understand the author's intent to address the needs of indigent patients to secure access to medications; however, this bill in its current form eliminates existing patient protections established in state and federal law and, if improperly done, could harm patients. Analysis Prepared by: Dharia McGrew / HEALTH / (916) 319-2097 FN: 0000357